Optetrak 244-24-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10885862064042), received between Aug 7, 2020 and Sep 4, 2024 — classified as 11 injuries.

The most frequently reported specific device problem is “Naturally Worn” (9 reports).

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K033883); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Aug 30, 2021Class IIOpen, Classified

   Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

   Z-0019-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 152 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. PLAINTIFF HAS SUFFERED THE FOLLOWING INJURIES, INCLUDING BUT NOT LIMITED TO, REHABILITATION, PAIN AND SUFFERING, PAST COST OF MEDICAL CARE, FUTURE COST OF MEDICAL CARE, LOSS OF EARNING CAPACITY AND MENTAL AND EMOTIONAL LOSS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Emotional Changes; Pain

  MAUDE report 20134313 ↗
• InjurySep 4, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 152 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. PLAINTIFF HAS SUFFERED THE FOLLOWING INJURIES, INCLUDING BUT NOT LIMITED TO, HAVING TO UNDERGO A REVISION SURGERY, REHABILITATION, PAIN AND SUFFERING, PAST COST OF MEDICAL CARE,FUTURE COST OF MEDICAL CARE, LOSS OF EARNING CAPACITY AND MENTAL AND EMOTIONAL STRESS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Pain

  MAUDE report 20134205 ↗
• InjuryAug 26, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA THE LEGAL DEPARTMENT THAT THIS PATIENT'S RIGHT KNEE WAS REVISED APPROXIMATELY 4 YEARS 9 MONTHS POST OP. REASON FOR THE REVISION WAS NOT REPORTED. NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 20072424 ↗
• InjuryJun 19, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT WAS IMPLANTED WITH AN OPTETRAK CLASSIC DEVICE ON THE RIGHT KNEE AND THEN APPROXIMATELY 11 YEARS, 9 MONTHS LATER THE PATIENT WAS REVISED. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO DEVICE RETURN. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19571088 ↗
• InjuryApr 18, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2011, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2017 APPROXIMATELY 5 YEARS AND 11 MONTHS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Implant Pain; Inadequate Osseointegration; Muscle/Tendon Damage; Nerve Damage; Osteolysis; Pain

  MAUDE report 19131334 ↗
• InjuryDec 29, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6)2009. APPROXIMATELY 13 YEARS AND 1 MONTH AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2022. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A COORDINATED ACTION IN ALACHUA COUNTY WITH MASTER CASE (B)(4). THE CONSOLIDATED LONG FORM COMPLAINT THAT APPLIES TO CASES FILED IN THIS COORDINATED ACTION ALLEGES THAT PATIENTS FILING SUITS IN THIS COORDINATED ACTION WERE REQUIRED ¿TO UNDERGO REVISION SURGERIES DUE TO SEVERE, PAIN, SWELLING, AND INSTABILITY¿ DUE TO ¿WEAR OF THE POLYETHYLENE COMPONENTS AND RESULTING COMPONENT LOOSENING AND/OR OTHER FAILURE FAILURES CAUSING SERIOUS COMPLICATIONS INCLUDING TISSUE DAMAGE, OSTEOLYSIS, PERMANENT BONE LOSS, AND OTHER INJURIES.¿ BECAUSE THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN THIS COORDINATED ACTION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT

  Patient problems: Insufficient Information

  MAUDE report 18418392 ↗
• InjuryJun 14, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY FIVE YEARS POST INITIAL RIGHT TKA, THE 61 Y/O MALE HAD A PREMATURE POLYETHYLENE WEAR AND DELAMINATION OF INSERT RESULTING IN GRANULOMA AND MASSIVE OSTEOLYSIS WITH LOOSENING OF FEMORAL COMPONENTS AND SIGNIFICANT BONE DEFECTS MEDIAL AND LATERAL FEMORAL CONDYLES. PATIENT REVISED TO COMPETITOR'S COMPONENTS WITH SLEEVES AND STEM EXTENSIONS AND ALLOGRAFT BONE GRAFTING TO FEMUR. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. IMAGE RECEIVED. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED BY HOSPITAL. AS OF NOTE: "PATIENT HAD SIGNIFICANT BONE LOSS AT THE TIME OF REVISION SURGERY AND IS UNLIKELY TO RETURN TO PRE-MORBID LEVEL OF ACTIVITY".

  Patient problems: Failure of Implant; Granuloma; Osteolysis

  MAUDE report 17126524 ↗
• InjuryOct 11, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED VIA A LEGAL NOTIFICATION THAT A MALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2007, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 14 YEARS 11 MONTHS POST THE INITIAL IMPLANT PROCEDURE FOR REASONS UNKNOWN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15583878 ↗
• InjuryAug 25, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A MALE PATIENT, WHO HAD THEIR RIGHT KNEE INITIALLY IMPLANTED ON (B)(6) 2014, WAS BROUGHT BACK FOR RIGHT KNEE PAIN APPROXIMATELY 7 YEARS 10 MONTHS THE INITIAL IMPLANT PROCEDURE. THE POLY WAS REMOVED WITH SIGNIFICANT WEAR. THE TIBIA WAS FOUND TO BE LOOSE AND REMOVED AS WELL. THE PATIENT RECEIVED A TRULIANT 4/3 TIBIAL TRAY, 13MM STEM, A STEM EXTENSION SCREW, AND A NEW SIZE 15MM PS HIGH FLEX INSERT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICE RETURNING AS THE PATIENT HAS REQUESTED THE IMPLANTS.

  Patient problems: Pain

  MAUDE report 15292813 ↗
• InjuryOct 15, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A LEFT KNEE REVISION SURGERY ON (B)(6) 2010, DUE TO INSTABILITY. INITIAL SURGERY DATE WAS (B)(6) 2007. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10687549 ↗
• InjuryAug 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, A (B)(6) Y/O, MALE PATIENT WITH A BMI OF 33.3 UNDERWENT IMPLANTATION OF A INSERT TIB 4 11MM KNEE POST STAB OPTETRAK HFLEX. ON (B)(6) 2019, APPROXIMATELY 22 MONTHS POST IMPLANT, THE PATIENT UNDERWENT REVISION DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 10381921 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033883. One submission often covers many models, so check the product and lot details in each record.

• Z-0584-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
• Z-0021-2022 · Aug 30, 2021 · Open, Classified
  OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts,
• Z-0906-2015 · Oct 9, 2014 · Terminated
  Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants